FDA Drug recall D-0837-2018
My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharma…
- FDA Drug
- Class II
- terminated
- Published 2018-05-30
On 2018-05-30 the FDA classified a Class II recall of My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharma… by Lupin Pharmaceuticals, citing marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0837-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-17 |
| Published | 2018-05-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
Reason
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Identifiers
| upc | 343386622313 |
|---|---|
| code_info | Lot #: M16317A1, M16317A4, M16317A5, Exp 11/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0837-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.